Development of an advanced database for clinical trials integrated with an electronic patient record system

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Abstract

Secondary use of patient databases is essential in healthcare if clinical trials are to progress efficiently to planned time and target and imperative if the planned UK expansion of research and development (R&D) at point of care is to be achieved. Integration of effective databases primarily designed to facilitate patient care with R&D requirements is needed but represents a complex challenge.

We present a system that achieves an integrated approach with online management of complex datasets for clinical trials within care records using a specific study as an example to show functionality in practice; illustrating how this system provides an ideal resource to meet the needs of both clinicians and researchers.

Highlights

► We present the first use of an integrated database for clinical and clinical research purposes. ► Technical aspects of this new application are detailed. ► Practical use of the integrated database in a clinical study is described. ► The development and use of this new database meets UK aspirations for best practice.

Introduction

In recent years there has been a huge drive from both within and outside the National Health Service (NHS) to develop and refine Information Technology systems for healthcare. In an ever more complex global setting, advances in care depend on well conducted and robust clinical trials. This close relationship between the needs of healthcare professionals and researchers gives impetus to the use of health information technology that can provide integrated systems to facilitate the organisation and day to day management of clinical trials and to disseminate findings into clinical care. Provision of access for clinical researchers to patient data that protects individual interests and allows research to proceed effectively is a core recommendation of the Academy of Medical Sciences review of regulation and governance of health research [1].

The UK government set up a national information technology programme (NPfIT) in 2002, into which they agreed to invest £18bn over the following 10 years [2] which aims to provide a comprehensive electronic records infrastructure. Electronic patient records, created at the point of care, will be accessible to authorised users in primary, secondary, tertiary and community care as well as to patients themselves, making necessary information available at a time and place convenient to all involved. The database of patients created by Spine (NPfIT) will have almost 50 million patients; this will create one of the largest databases of patients in the world [3].

Although primarily used to facilitate coordination of the care pathway, this system can also be of enormous value in the area of research and clinical trials. The commitment to clinical research in an NHS setting has been confirmed by the creation of the National Institute for Health Research (NIHR) [4], which brings coordinated research support and infrastructure to clinical trials in all areas of medicine and which is tasked with delivery of clinical research to time and to target. The NHS Constitution has further affirmed its commitment to innovation and the conduct of research to improve the current and future health of the population [5].

Integration of patient care and clinical trial databases would achieve much to support these ambitious goals in advancing healthcare through robust clinical research. A reliable and acceptable technology platform for both clinical and research communities is essential if the aims of the NIHR and NHS Constitution are to be realised.

Current strategy reviews in cancer care highlight the promise of new therapies but also the potential burden of their adoption [6]. As the clinical environment in which care is given becomes ever more complex, the Department of Health (DH) is committed to gathering robust data for benchmarking and service development. The Improving Outcomes: A Strategy for Cancer report emphasises the place of the patient at the core in the delivery of healthcare, healthcare innovation and research [7].

Integration with a clinical trials record will be helpful, especially in multi-centre studies where the investigators and researchers need access to patient details in a convenient way. For cancer research it is estimated that 25% of UK patients will access healthcare, and potentially cIinical research, through the emergency care pathway; therefore, information must be available about involvement in research, especially trials of new therapeutic agents to enable safe management at the point of care. In Leeds, UK, the Patient Pathway Manager (PPM) system (developed in Leeds and described below) is now being used routinely as an integrated resource.

The system developed in response to need to bridge the gap in knowledge between informatics and researchers, as most software is fairly difficult to use. The software and the system, described in this paper, have been designed to be user friendly and provide real time data. Though some training is required, the interface can be easily understood; allowing seamless integration of patient records and research data, which can be analysed. The data can be obtained in different ways, i.e. through online or on stand-alone systems, which can then be synchronized with the main data on the server.

The data technology system was initially developed to support oncology clinical research but has now been rolled out to embrace all clinical disciplines. LTHT is the largest NHS Trust in the UK with a considerable cancer related workload allied to a strong research programme across all aspects of cancer diagnosis, treatment and patient and carer support. In accordance with the National Institute for Health and Clinical Excellence (NICE) national guidelines for improving outcomes [8], patients are managed by a team combining all relevant medical specialist expertise and that of nurses and allied health professionals, the multidisciplinary cancer team (MDT). Patient Pathway Manager (PPM) is now the core resource for integrating cancer care across various Trust sites. The patient “pathway” refers to all the key stages in a patient's care episode from initial referral through diagnosis and treatment to follow-up and outcomes, including reports of clinical tests, chemotherapy prescriptions, imaging and pathology reports to provide a comprehensive record of care.

At all points in the pathway, there is potential for recruitment to a clinical trial. Managing such activity in isolation carries a number of generic risks:

  • Patients may be approached for entry after they have already refused.

  • Patients may be asked to take part in more than one clinical trial, with ethical implications as well as governance issues when trials conflict.

  • Health professionals in both hospital and primary care settings may not know that a patient has been entered into a trial, an event which might affect their management.

Integration of clinical trial management with the care pathway can overcome these practical problems.

To assess the place of PPM as a research database linked to clinical practise initial feasibility work was undertaken with the Cancer Research UK funded Psychosocial Oncology and Clinical Practise Research Group in Leeds. This research team has undertaken substantial research into the use of touch-screen computers in health related quality of life (HRQoL) research, successfully capturing data from patients in an acceptable and reliable way [9]. The use of touch-screen technology has proved very successful in investigating HRQoL in patient populations. The ability to rapidly collect and automatically score data allows the doctor easy access to information about present and cumulative HRQoL [10]. This intervention resulted in an increase in the number of issues discussed at consultation and patients considered questionnaires a useful tool to inform their doctors about their problems. The benefit of making HRQoL scores readily available at clinic through availability of touch-screen data, in terms of identification of issues and patient satisfaction, has been demonstrated by randomised control trials [11], [12]. This work opened the path to a full clinical/research electronic database combining the clinical pathway, clinical trials management and direct entry of patient generated data that has revolutionised the way study participants are recruited by the clinical team and questionnaire data is gathered and stored by the clinical researchers. With the use of new generation on-line touch screen data collection systems since January 2006 eligible patients can be easily identified on PPM by clinicians and drawn directly into the pathway for invitation to enter studies, thus meeting the requirements of the NHS Constitution whereby clinical teams have a duty to inform their patients of clinical trials which they are eligible to enter [5]. Once successful completion of the interactive touch screen questionnaires has taken place, data collected can be either automatically or retrospectively uploaded into PPM.

To illustrate this system and to allow a description of the practical functionality, from a user perspective, we report a study assessing HRQoL in head and neck (H&N) cancer patients, carried out at a number of geographical sites within LTHT; showing the benefits provided by a system, which electronically links clinics and uploads and downloads data to and from a secure site.

Section snippets

Patient pathway manager (PPM)

The Patient Pathway Manager (PPM) is an integrated information and data management system. It is the Cancer Information System for Leeds Teaching Hospital Trust (LTHT) and, with the encouragement of the Yorkshire Cancer Network, instances of PPM are now running live beyond LTHT, in the Calderdale, Bradford, York and the Mid-Yorkshire Trusts and is also now being deployed to other, non-cancer related services.

PPM has been built around a standard SQL Server 2005 infrastructure and is viewed and

The clinical setting

Head and neck (H&N) cancer represents a global healthcare challenge [13] with oral cancer alone accounting for 220,000 new cases in males and 90,000 in females annually worldwide, representing 5% and 2%, respectively, of new cancer diagnoses. In the USA, 36,234 new cases of H&N cancer were reported in 2003 [14] and in England, 6036 cases in 2006 [15]. The complexity of management of this cancer with challenges to key functions such as speech and eating as well as aesthetic morbidity makes a H&N

Patient identification and clinical records

The introduction of PPM as a base for the clinical record allows staff to log on, identify a patient and access medical notes, diagnostic summaries, reports and annotations. The use of a core dataset for generic data for clinical care and research avoids errors in entry and completion of a separate and potentially less secure set of records. As well as integrating care and research records within the MDT, other teams can access essential information when the patient has other problems, an

Discussion

In view of recent plans for and massive investment in modern NHS recording and communication systems, the incorporation of the PPM system into clinical services at the LTHT has been most timely. Furthermore, the integration of this system with ongoing research within the CR-UK Oncology Psychosocial and Clinical Practice Research Group is very much in line with the major national recommendations for bringing together clinical research and clinical care. The advantages of using new generation

Summary

This paper presents a practical example of use of an integrated database for primary and secondary purposes. This development is fundamental to the future of research and development in healthcare and to the ever increasing wish to integrate clinical care between the community and hospital based settings.

It aims to bring awareness of the issues to be addressed in achieving integration and outlines practical solutions. The material presented is part of an evolving research and clinical

Conflict of interest statement

Our involvement in this study was as noted. Colin Johnston, Geoff Hall and Michael Leahy, as inventors of the PPM system may have a commercial interest should it be adopted more widely in healthcare. The other authors confirm that we have no conflict of interest arising from this paper.

Acknowledgements

The authors wish to acknowledge the support of the Psychosocial Oncology and Clinical Practice Research Group through a Cancer Research UK Programme Award and support for the Head and Neck Cancer study from the British Association of Oral & Maxillofacial Surgeons and the Charitable Trustees of the Leeds Teaching Hospitals NHS Trust, the THOR (Translational Head and Neck Oncology Research) Group, University of Leeds, the clinicians and the patients.

The sponsor for the clinical study is the

Alexander C. Newsham, has over eleven years' worth of experience as a Data Manager, Programmer and Database Developer. Having previously worked as a Clinical Data Scientist and Clinical Data Management Team Leader in the Pharmaceutical industry, Alex has spent the last five years working in various fields of cancer research. His current position as the CR-UK Senior Data Manager and Database Developer at the Cancer Medicine Research Unit, CR-UK Clinical Centre in Leeds, involves developing

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Alexander C. Newsham, has over eleven years' worth of experience as a Data Manager, Programmer and Database Developer. Having previously worked as a Clinical Data Scientist and Clinical Data Management Team Leader in the Pharmaceutical industry, Alex has spent the last five years working in various fields of cancer research. His current position as the CR-UK Senior Data Manager and Database Developer at the Cancer Medicine Research Unit, CR-UK Clinical Centre in Leeds, involves developing systems and providing data and programming solutions for a wide range of academic and translational oncology research activities as well as contributing to departmental research papers. Immediately prior to his time at Leeds, Alex held a similar role with Professor Leslie Fallowfield's Psychosocial Oncology Group at the University of Sussex. He was awarded an MA with distinction from Birkbeck College, University of London, in 2000.

Colin Johnston, has been the driver for the development of the PPM system. A statistician by background, he has been aware of the potential for electronic records to revolutionise health care and health research. Working with clinical colleagues in the Section of Oncology at the University of Leeds and with the Leeds Teaching Hospitals NHS Trust, he has been primarily responsible for the creation of the electronic records system which now forms the core of oncology care in the hospital and which links seamlessly to the partner and University based clinical trials system as described in this paper.

Geoff Hall, is a Senior Lecturer in Medical Oncology at the University of Leeds. He received his medical degree from the University of Sheffield in 1990, a Ph.D. from the University of Leeds in 1993 and completed specialist training in Medical Oncology in 2001. As an Honorary Consultant at the St James's Institute of Oncology, Leeds, his clinical practice focuses on the care of women with gynaecological malignancies and is part of an academic research group assessing the efficacy of targeted therapy in gynaecological malignancies. Since starting work in oncology, he has had a particular interest in the use of Informatics to enhance patient care. He is now the Clinical Lead and Chair of the PPM Senior Management Board and helps guide the overall development and delivery of this comprehensive clinical database/electronic patient record which collates information on all cancer patients treated within St James's Institute of Oncology and associated cancer units across the Yorkshire Cancer network. He has recently been appointed as the Lead Clinician for Cancer at the Leeds Teaching Hospitals Trust.

Michael Leahy, is a full time medical oncologist in sarcoma, germ cell cancer and teenagers and young adults with cancer. He trained in London and Manchester and was appointed as Senior Lecturer/Consultant in Medical Oncology in Leeds between 1998 and 2005 and is now working at The Christie in Manchester. He has no academic qualification in IT but has been involved in database design and management with particular reference to clinical data since medical school and has attended a number of relevant training courses. He has used these skills to support his clinical and research practice throughout his career.

Adam B. Smith, previously worked for the CR-UK Psychosocial and Clinical Practice Research Group at Leeds for over ten years where he was involved in the original design and development of the touch-screen computer systems for collecting quality of life information from patients and more recently as a lecturer in quantitative methods at the Leeds Institute for Health Sciences. His main research interest lies in the application of modern psychometric methods such as Rasch and Item-response Models to health data. Adam's research has focused on developing and assessing computer-assisted questionnaires to measure and assess quality-of-life and psychological well-being. His recent work has involved the development of item banks and computer-adaptive tests for screening for psychological distress.

Aditya Vikram, is a dentist by clinical discipline whose research interests focus on Quality of Life in Head and Neck Cancer patients. He holds a Postgraduate Qualification (MFD) from the Royal College of Surgeons in Ireland. He has an interest in Head and Neck cancer and has worked as a clinician in Oral & Maxillofacial Surgery. He has clinical experience as a Senior House Officer in Oral & Maxillofacial Surgery in a number of UK hospitals, giving insight into the care of Head and Neck cancer patients. His recent post was Research Assistant in the University of Leeds working towards the development of a ‘Patient specific Questionnaire for Head and Neck Cancer patients’.

Aine M. Donnelly, was a Research Assistant in the Psychosocial Oncology Group at the University of Leeds. Her role involved managing data collection and the day-to-day management of research looking at Quality of Life assessment as part of routine care in Head and Neck cancer patients. She was awarded a Masters Degree in Health Psychology from the University of Bath where she conducted research investigating Quality of Life in Heart and Lung transplant candidates.

Galina Velikova, Professor Velikova obtained her medical degree from the Medical Institute, Varna, Bulgaria in 1986 and a specialty degree in Internal Medicine in Bulgaria in 1994. She completed specialist training in Medical Oncology in UK in 2001. She obtained a PhD from the University of Leeds 2001 for a research degree project “Quality of life measurement in daily oncology practice”. Prof Velikova leads a research group funded by a Cancer Research UK programme grant in psycho-social oncology to study the implementation of routine measurement of patient-reported outcomes and quality of life in oncology practice. She is a Consultant in Medical Oncology and a Senior Lecturer at the University of Leeds. Her clinical work focuses on systemic treatment of breast cancer patients. She leads the quality of life sub-studies of large national trials in breast cancer. Prof Velikova is chair of British Psychosocial Oncology Society (BPOS) and a member of UK National Cancer Research Institute Psychosocial Oncology Study Group. She is chair of EORTC Quality of Life Group and Board member of International Society of Quality of Life research.

Peter J. Selby, was, until 2010, Joint Director of the National Institute for Health Research Clinical Research Network with Professor Janet Darbyshire. Peter is Professor of Cancer Medicine, Director of the Leeds Institute of Molecular Medicine and a Consultant Physician at St James's University Hospital. Before taking up that post he was at the Royal Marsden Hospital and Institute of Cancer Research in London and the Ontario Cancer Institute, Toronto. His research interests include biomarkers and biological therapy and clinical trials and his clinical work is mainly with urological cancer patients. Peter was formerly the Director of the National Cancer Research Network and is President of the Association of Cancer Physicians.

Sheila E. Fisher, is Associate Director for Patient and Public Involvement at the National Cancer Research Institute and National Cancer Research Network and Clinical Research Fellow, University of Leeds. Her surgical practice centred on the care of patients with head and neck cancer and facial trauma and she was appointed Consultant Maxillofacial Surgeon to the University Hospital, Nottingham in 1992. In 2000 she moved to the University of Leeds as Senior Lecturer/Hon Consultant in Maxillofacial Surgery, where her research interests include new diagnostic and therapeutic interventions in the care of patients with head and neck cancer and assessment of quality of life as part of routine care. She holds a Senior Research Fellowship at the University of Bradford. She has been a member of a number of Department of Health strategy groups for H&N Cancer care and a member of the National Cancer Research Institute (NCRI) H&N Clinical Studies Group and Chair of the Survivorship subgroup.

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